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KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today reported financial results for the three and nine months ended September 30, 2012, and provided an update on recent accomplishments.
“We have been very productive in the last few months, during which we advanced our clinical development program and strengthened our capital position through the successful completion of our initial public offering with gross proceeds of $81 million,” said Keith Leonard, KYTHERA’s President and CEO. “Importantly, we completed enrollment in our pivotal U.S. and Canadian Phase III clinical trials of ATX-101, an injectable facial aesthetic drug under clinical investigation for the reduction of submental fat, and remain on track to report data from this trial in mid-2013. We are pleased with the continued progress of the development of ATX-101 as part of our long-term vision to build KYTHERA into a leading aesthetics company.”
Selected Financial ResultsCash and cash equivalents totaled $15.1 million at September 30, 2012. This compares to $34.6 million at December 31, 2011. Subsequent to the close of the third quarter, the Company successfully completed its Initial Public Offering, receiving net proceeds of approximately $72.6 million after deducting underwriting discounts, commissions and estimated offering costs.
Research and development expenses totaled $13.9 million for the third quarter and $28.8 million for first nine months of 2012, compared to $3.2 million for the third quarter and $9.6 million for the first nine months of 2011. The increase in R&D expenses in the three month and nine month periods of 2012 compared to the similar periods in 2011 is attributable to the initiation of pivotal Phase III trials in the U.S. and Canada around year-end 2011. These trials are now fully enrolled.
General and administrative expenses totaled $2.4 million for the third quarter and $7.1 million for the first nine months of 2012, compared to $1.7 million for the third quarter and $4.9 million for the first nine months of 2011.
Net loss for the third quarter ended September 30, 2012 was $16.4 million compared to a net loss of $2.3 million for the same period ended September 30, 2011. Net loss for the nine months ended September 30, 2012 was $18.8 million compared to $5.5 million for the same period ended September 30, 2011.
Progress Toward 2012 Key Milestones and Objectives
In the past few months, KYTHERA announced the following achievements:
Completion of enrollment in two pivotal U.S. and Canadian Phase III clinical trials of ATX-101, a potential first-in-class injectable facial aesthetic drug under clinical investigation for the reduction of submental fat.
Closing of its initial public offering of 5,060,000 shares of its common stock at an initial public offering price of $16.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 660,000 additional shares of common stock. The Company received net proceeds of approximately $72.6 million after deducting underwriting discounts, commissions and estimated offering costs.
ATX-101 is a proprietary formulation of synthetic sodium deoxycholate, a well-characterized component of human bile that is naturally occurring in the body to promote the breakdown of dietary fat. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Based on clinical trials conducted to date, ATX-101 has exhibited significant, meaningful and durable results in the reduction of submental fat, which commonly presents as an undesirable “double chin.” These results correspond with patient satisfaction measures demonstrating meaningful improvement in perceived chin appearance.